The ultimate objective of this program is to develop a novel therapeutic approach that will save lives of patients with stroke. Acute stroke is the third leading cause of death in the United States and the primary medical cause of acquired adult disability. Each year, ~795,000 Americans experience new or recurrent stroke. It accounts for 1 out of every 18 deaths in the United States. As the population ages, stroke care costs are expected to increase substantially. The direct medical costs for stroke care are estimated to increase from $28.3 billion in 2010 to $95.6 billion in 2030. Despite its prevalence, current treatment options are very limited and stroke survivors still encounter serious morbidity issues. The development of safe and effective therapeutics to treat stroke patients remains a major challenge to the pharmaceutical industry. Human ghrelin, a novel gastrointestinal hormone, was first identified as the endogenous ligand for the growth hormone secretagogue receptor type 1a (i.e., ghrelin receptor). Ghrelin freely crosses the blood brain barrier (BBB) and has been reported to induce growth hormone release through stimulation of ghrelin receptor in the central nervous system. However, sufficient evidence has pointed out other physiological functions of ghrelin in addition to its role in growth hormone release. Using an animal model of permanent middle cerebral artery occlusion (i.e., ischemic stroke), our preliminary studies have shown that human ghrelin treatment improved neurological function, reduced infarct size, and increased survival. The primary objective of this project is targeted towards demonstrating the feasibility o the further development and commercialization of human ghrelin as a novel therapeutic agent for stroke patients. Animal models of ischemic stroke with or without reperfusion will be used. The optimal dosage(s) and therapeutic window will be determined by assessing the dose-dependent effect of human ghrelin on brain injury and the time-course of human ghrelin's beneficial effects after stroke. Furthermore, we will investigate the long-term effect of human ghrelin on motor function impairment after ischemic stroke with or without reperfusion. Our future goal (SBIR Phase II and beyond) is to obtain commercial utilization of human ghrelin as a safe and effective therapy for patients suffering from stroke.

Public Health Relevance

Acute stroke is the third leading cause of death in the United States and the primary medical cause of acquired adult disability. Currently in the United States, there are over 4.7 million stroke survivors, with ~795,000 people suffering from new or recurrent stroke each year. Every 45 seconds in the United States, someone experiences stroke. Over the course of a lifetime, four out of every five American families will be touched by stroke. The economic and social costs of this illness constitute an increasing burden to our society. Despite its prevalence, current treatment options are very limited. Thus, there is a pressing unmet medical need for a novel and effective therapy for stroke patients.

National Institute of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1)
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Fertig, Stephanie
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Therasource, LLC
United States
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